Although officially part of China, Hong Kong is a Special Administrative Region and maintains its own regulatory framework for medical devices. The Medical Device Control Office (MDCO) oversees medical devices in Hong Kong, but no specific regulation is currently in place regarding importation, distribution or sale of devices.
Formal regulations are expected to be introduced in the near future, however, and in the meantime MDCO has set up voluntary guidelines to assist manufacturers move to a more regulated environment in Hong Kong. Compliance guidelines in Hong Kong, contained in the Medical Device Administrative Control System (MDACS), are based on Global Harmonization Task Force (GHTF) guidelines.
To register your device with MDCO, you must first determine your product’s classification—as in other markets, Hong Kong uses a four-tier classification system (Class I-IV) based on risk. This is important because currently only Class II, III and IV medical devices can be voluntarily listed on MDACS. Class I devices cannot be registered.
Emergo Group’s Hong Kong office has the knowledge and experience to support your registration effort—and to prepare for a more formalized regulatory environment in Hong Kong once new rules are introduced.